Omission of ALND in Breast Cancer Patients with Axillary PCR

Trial Title: Omission of ALND in Breast Cancer Patients with Axillary PCR

NCT ID: NCT05939830

Condition: Axillary Lymph Node Dissection
Pathological Complete Response
Neoadjuvant Systemic Therapy
Breast Cancer
Axillary Lymph

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
Breast Cancer
Neoadjuvant Systemic Therapy
Axillary Surgery

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Stained region Lymph Node Biopsy (SrLNB)
Description: Before NST, positive lymph nodes would be marked with localized titanium clips under ultrasound guidance, and carbon nanoparticles suspension would be injected into the cortex of the marked lymph nodes and surrounding suspicious lymph nodes for staining. Marked and stained lymph nodes will be removed and biopsied after NST.
Arm group label: Omit ALND

Intervention type: Radiation
Intervention name: Regional lymph node radiotherapy (RNI) including the axilla
Description: RNI including the axilla covers the supraclavicular region and entire axillary lymphatic drainage area (region I, II and III) ,and is at a dose of 50 Gy/25 times, with additional prophylactic irradiation of the internal breast lymphatic drainage area for eligible patients.
Arm group label: Omit ALND

Summary: This prospective, single-arm, phase II trial studies axillary lymph node dissection (ALND) to see if it can be safely omitted in breast cancer patients with axillary pathological complete response (pCR) after neoadjuvant systemic therapy (NST). Breast cancer patients with biopsy-proven positive axillary lymph nodes at initial diagnosis, and converted to negative after NST, which is confirmed by Stained region Lymph Node Biopsy(SrLNB), will be enrolled in the study. In other words, a total of 92 patients will be exempted from ALND after SrLNB, and afterwards complete regional node irradiation (RNI) including the axilla. They will also undergo adjuvant chemotherapy, targeted therapy, endocrinotherapy after surgery. These patients will be followed up in the next three years for local-regional recurrence and long-time survival outcome.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Female aged between 18 and 70 years; 2. Pathologically confirmed invasive breast cancer (regardless of pathological type) with a clinical stage cT1-3; 3. Pathologically confirmed positive axillary lymph nodes with a clinical stage of N1-3; 4. Receiving a full course of neoadjuvant therapy (including neoadjuvant chemotherapy, neoadjuvant targeted therapy, neoadjuvant immunotherapy); 5. Positive axillary lymph nodes successfully stained by carbon nanoparticles injection with/without titanium clip marking; 6. All patients are required to undergo immunohistochemical staining for Estrogen Receptor (ER), Progesterone Receptor (PR), human epidermal growth factor receptor 2 (HER2), Ki- 67 proliferation index, and further fluorescence in situ hybridization (FISH) should be performed in HER2 2+ cases; 7. Preoperative clinical assessment (including physical examination, imaging, with or without nomogram assessment) suggests positive axillary lymph nodes converted to negative (ycN0); 8. ECOG score 0 - 1; 9. Patients voluntarily participated in this study and signed the informed consent form Exclusion Criteria: 1. Bilateral breast cancer; 2. Breast cancer during lactation period or pregnancy; 3. Physical examination or imaging examination confirmed presence of distant metastases; 4. Previous history of malignant tumor; 5. History of previous surgery on the affected axilla; or history of surgery affecting the function of the upper extremity; 6. History of radiation therapy to the breast or chest; 7. Positive incision margins for breast-conserving surgery/mastectomy; 8. Positive results of intraoperative rapid freeze pathology (including isolated tumor cells and micrometastases) for SrLNB (ypN+); 9. Those who unable to complete the full course of follow-up adjuvant therapy as prescribed for various reasons; 10. Aspartate transaminase (AST) and alanine transaminase (ALT) ≥ 1.5 times the upper limit of normal, alkaline phosphatase（ALP） ≥ 2.5 times the upper limit of normal, total bile ≥ 1.5 times the upper limit of normal, serum creatinine ≥ 1.5 times the upper limit of normal; Left Ventricular Ejection Fractions (LVEF) < 50% in cardiac ultrasound; 11. Severe coagulation dysfunction, serious systemic disease, or uncontrolled infection; 12. Without personal freedom and independent civil capacity; 13. Those with mental disorders, addictions, who were not eligible for enrollment in the judgment of the investigator.

Gender: Female

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: The First Affiliated Hospital of Nanjing Medical University

Address:
City: Nanjing
Country: China

Status: Recruiting

Contact:
Last name: Lingjun Ma

Phone: +8613186693728
Email: malingjun@stu.njmu.edu.cn

Start date: September 11, 2023

Completion date: July 2026

Lead sponsor:
Agency: The First Affiliated Hospital with Nanjing Medical University
Agency class: Other

Source: The First Affiliated Hospital with Nanjing Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05939830